Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

DQY 1983-08-24

PERCUTANEOUS INTRODUCER KIT

Applicant Accu-Line

K-Number K831636

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JJQ 1983-08-24

SPECTROPHOTOMETER #390

Applicant Abbott Diagnostics

K-Number K832206

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IXJ 1983-08-18

AOR X-RAY ALIGMENT PAD

Applicant Zimmer, Inc.

K-Number K837776

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FTM 1983-08-16

FOIL IN 3 FORMS-NON-STERILE SHEETS

Applicant S. Jackson, Inc.

K-Number K831725

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CGA 1983-08-16

UNITIZED ENZYMATIC GLUCOSE TEST SET

Applicant Stanbio Laboratory

K-Number K832159

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CCQ 1983-08-16

INSPIREASE

Applicant Key Pharmaceuticals, Inc.

K-Number K832037

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N/A 1983-08-16

POLYCORE

Applicant Polycore Optical Pte , Ltd.

K-Number K832461

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JKC 1983-08-16

DHEA-SULFATE I RIA KIT

Applicant Diagnostic Systems Laboratories, Inc.

K-Number K832154

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HLJ 1983-08-16

MEDIC LUX DIAGNOSTIC SETS

Applicant Keeler Instruments, Inc.

K-Number K832437

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FRN 1983-08-16

AMBULATORY MARK III INFUSION DEVICE

Applicant Windsor Medical, Inc.

K-Number K830656

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DPM 1983-08-16

PRP-1 REVERSED PHASE COLUMNS FOR HPLC

Applicant Hamilton Co.

K-Number K832200

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N/A 1983-08-16

OCULOPRESSOR

Applicant Hans Gevder

K-Number K832477

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